Suprascapular Notch Cross-sectional Area Measured by Ultrasonography
Primary Purpose
Shoulder Pain, Shoulder Impingement Syndrome
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ultrasound
Sponsored by
About this trial
This is an interventional diagnostic trial for Shoulder Pain
Eligibility Criteria
Inclusion Criteria: chronic shoulder pain 35-65 years who agreed to participate in the study Exclusion Criteria: . Lymphoproliferative diseases and other neoplasms .Uncontrolled arterial hypertension Metabolic syndrome Uncontrolled diabetes mellitus Mental retardation Antidepressant use Autoimmune diseases
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
diseased shoulder
sturdy shoulder
Arm Description
Outcomes
Primary Outcome Measures
Suprascapular notch cross-sectional area measurement
The area under the suprascapular notch and the superior transverse scapular ligament is measured using the cross-sectional area measurement method.
Secondary Outcome Measures
Visual Analogue Scale
Visual Analog Scale was used for pain. Pain intensity was measured using 0-10 cm visual analogue scale (VAS). The findings suggested that 100-mm VAS ratings of 0 to 4 mm can be considered no pain; 5 to 44 mm, mild pain; 45 to 74 mm, moderate pain; and 75 to 100 mm, severe pain.
Shoulder Pain and Disability Index (SPADI)
The Shoulder Pain and Disability Index (SPADI) is a patient completed questionnaire with 13 items assessing pain level and extent of difficulty with activity of daily livings requiring the use of the upper extremities. The pain subscale has 5-items and the Disability subscale has 8-items.To score either version of the SPADI, the total score is calculated by averaging the pain and disability subscale scores to find a score out of 100. On this scale, 0 represents less disability while 100 represents greatest disability
Full Information
NCT ID
NCT05996510
First Posted
August 4, 2023
Last Updated
August 17, 2023
Sponsor
Bursa Yüksek İhtisas Education and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05996510
Brief Title
Suprascapular Notch Cross-sectional Area Measured by Ultrasonography
Official Title
Investigation of the Relationship Between Suprascapular Notch Cross-sectional Area Measured by Ultrasonography and Disease Activity in Subacromial Impingement Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 10, 2023 (Anticipated)
Primary Completion Date
October 10, 2023 (Anticipated)
Study Completion Date
October 11, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bursa Yüksek İhtisas Education and Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Chronic shoulder pain is one of the most common diseases affecting the quality of life today. Although there are multiple causes, one of the most common causes is shoulder impingement syndrome.
Ultrasound can be used for diagnosis in patients whose treatment is difficult due to its complex structure. While the supraspinatus muscle, tendon and shoulder joint are the regions that are usually evaluated, the visualization of the Suprascapular notch is usually observed during injection. The connection between the suprascapular notch and the shoulder joint has been demonstrated in different studies.
Detailed Description
In this study, the investigation of the relationship between the measurements of the suprascapular nerve and the suprascapular notch, which the investigators observed in our clinical ultrasound applications, and the disease activity intended.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Pain, Shoulder Impingement Syndrome
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
diseased shoulder
Arm Type
Active Comparator
Arm Title
sturdy shoulder
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
ultrasound
Other Intervention Name(s)
shoulder ultrasound
Intervention Description
Shoulder ultrasound is performed using a linear ultrasound probe. The area under the suprascapular notch and the superior transverse scapular ligament is measured using the cross-sectional area measurement method.
Primary Outcome Measure Information:
Title
Suprascapular notch cross-sectional area measurement
Description
The area under the suprascapular notch and the superior transverse scapular ligament is measured using the cross-sectional area measurement method.
Time Frame
baseline
Secondary Outcome Measure Information:
Title
Visual Analogue Scale
Description
Visual Analog Scale was used for pain. Pain intensity was measured using 0-10 cm visual analogue scale (VAS). The findings suggested that 100-mm VAS ratings of 0 to 4 mm can be considered no pain; 5 to 44 mm, mild pain; 45 to 74 mm, moderate pain; and 75 to 100 mm, severe pain.
Time Frame
baseline
Title
Shoulder Pain and Disability Index (SPADI)
Description
The Shoulder Pain and Disability Index (SPADI) is a patient completed questionnaire with 13 items assessing pain level and extent of difficulty with activity of daily livings requiring the use of the upper extremities. The pain subscale has 5-items and the Disability subscale has 8-items.To score either version of the SPADI, the total score is calculated by averaging the pain and disability subscale scores to find a score out of 100. On this scale, 0 represents less disability while 100 represents greatest disability
Time Frame
baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
chronic shoulder pain
35-65 years
who agreed to participate in the study
Exclusion Criteria:
. Lymphoproliferative diseases and other neoplasms
.Uncontrolled arterial hypertension
Metabolic syndrome
Uncontrolled diabetes mellitus
Mental retardation
Antidepressant use
Autoimmune diseases
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Burcu Ökmen, Assoc.Phd.MD
Phone
+905057081020
Email
burcumetinokmen@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
korgün ökmen
Organizational Affiliation
Bursa Yuksek Ihtisas Training and Research Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Lale altan inceoğlu, phd
Organizational Affiliation
uludağ university faculty of medicine
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
ugur ertem, M.D.
Organizational Affiliation
uludağ university faculty of medicine
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Suprascapular Notch Cross-sectional Area Measured by Ultrasonography
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